ICH: The Draft Guideline Q5A(R2) Reaches Step 2
On 11 October 2022, the ICH published the revised Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin as Step 2 document. This guideline addresses the testing and evaluation of the viral safety of biotechnology products and explains what data should be provided in the application dossier for the marketing and registration of these products.
Biotechnology products include biotherapeutics and certain biological products derived from cell cultures obtained from characterized cell banks of human or animal origin.
The draft ICH Q5A(R2) guideline reached Step 2 of the ICH process at the end of September 2022. In February 2024, Step 3 of the guideline is expected to be approved and Step 4 is expected to be adopted. The R2 revision retains the essential principles of the original 1999 guideline and includes additional recommendations on established and complementary approaches to control potential viral contamination of biotechnology products.
The Q5A(R2) EWG has prepared an informative overview summarizing the content of the draft guidance. More information is provided under Quality Guidelines in the section Q5A(R2), including the draft guideline and the Step 2 overview.
Source:
ICH: Guideline Q5A(R2)
ICH: Guideline Overview
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